Biogen Alzheimer’s Drug in FDA’s Court Following Completion of Filing

Xconomy Boston — 

By early September Biogen—plus the many scientists, patients, and investors following the saga of its controversial Alzheimer’s drug aducanamab—should know whether the FDA plans to review the Cambridge, MA biotech’s experimental brain disease treatment.

The company announced Wednesday that its submission to the FDA, pieces of which it has been submitting on a rolling basis, was complete. The Biogen (NASDAQ: BIIB) submission includes data from two Phase 3 trials and a Phase 1b study. Biogen’s announcement comes after it delayed the filing, which it in 2019 said would be complete in “early” 2020, to the third quarter.

Now the FDA has 60 days to decide whether to review the submission. During that time Biogen has also asked the agency to consider granting the filing priority review, a designation that would shorten its timeline to make a decision on whether to OK the drug for marketing in the US from the customary 10 months to six months.

In March 2019, aducanumab, which Biogen has been developing with Japan’s Eisai, became just another failed attempt to make a difference for patients with Alzheimer’s disease. The experimental treatment was designed to remove amyloid beta, a protein whose buildup has been associated with the disease’s progression.

But later that year, in a shocking about-face, Biogen revealed it intended to request that the FDA to review the drug after all. The biotech cited the results of an analysis of a larger dataset than the one used to make the decision to end the aducanumab program in March as its rationale for the drug’s revival.

In a research note sent this morning, SVB Leerink analyst Marc Goodman said it’s likely that if the FDA accepts the drug for review, it will also grant Biogen’s request for an expedited ruling.

Goodman predicted the agency will approve the drug in early 2021, although he noted that industry opinions remain sharply divided over whether the data Biogen has provided are sufficient to prove the drug’s efficacy. One of the Phase 3 trials evaluating aducanumab met its main goal, while the other did not.

“We admit that aducanumab’s data package is not as clean as we would hope, and that many Alzheimer’s specialists don’t think the drug should be approved based on the current data set; however, there are other [key opinion leaders] we have spoken with who still expect approval (from a risk/reward and high unmet need perspective in Alzheimer’s) and admit that any new disease-modifying drug is good news and will be tried in many Alzheimer’s patients,” he wrote.

Shares of Biogen rose 4 percent Wednesday to $280.19 apiece.

Image: iStock/sudok1

Want more Xconomy content? Subscribe today for free newsletters, event and webinar alerts, whitepapers, podcasts, and more.